marketing authorization application


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marketing authorization application

A complete dossier of information, including chemical, pharmaceutical, biological and clinical data, that is sent to a regulatory authority to support a request for marketing authorisation in the European Community.
References in periodicals archive ?
(NASDAQ: SRNE) majority-owned subsidiary, Scilex Pharmaceuticals Inc., has filed the European Marketing Authorization Application (MAA) for its lead product candidate, ZTlido (lidocaine medicated plaster 1.8%), through a hybrid regulatory pathway with the Medicines and Healthcare products Regulatory Agency in the UK, the company said.
- US-based biopharmaceutical company Gilead Sciences, Inc.'s (NASDAQ: GILD) Marketing Authorization Application for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus -infected patients has been fully validated and is now under assessment by the European Medicines Agency, the company said.
Raptor Pharmaceutical Corp (Nasdaq:RPTP) on Monday announced that the European Medicines Agency (EMA) has determined that it's Marketing Authorization Application (MAA) for its investigational drug candidate RP103, submitted earlier this month, is valid.
It added, Acceleron and Celgene remain on track to submit a Marketing Authorization Application to the European Medicines Agency for luspatercept in patients with anemia related to lower-risk MDS and beta-thalassemia in the first half of 2019...The ongoing Phase 2 trial of luspatercept in patients with MF has completed target enrollment, with preliminary results expected in the second half of 2019...Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with first-line lower-risk MDS and the BEYOND Phase 2 trial in patients with non-transfusion-dependent beta-thalassemia, with preliminary results expected from the BEYOND trial in 2020."
The naproxcinod Marketing Authorization Application (MAA) submitted by NicOx in December 2009 is currently under review by the European Medicines Agency (EMA).
In Q1, Audentes anticipates receiving scientific advice from the EMA that will begin to define the path toward submission of a European Marketing Authorization Application.
Stemline announced that the European Medicines Agency, or EMA, has completed its validation of the marketing authorization application, or MAA, for Elzonris.
Novartis announced that both the FDA and European Medicines Agency have accepted the company's New Drug Application, or NDA, and Marketing Authorization Application, or MAA, respectively, for investigational oral, once-daily siponimod for the treatment of secondary progressive multiple sclerosis in adults.
The comprehensive data package, submitted as part of the marketing authorization application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.
Bayer plans to submit a Marketing Authorization Application in the European Union in 2018.
Sarepta (SRPT), down 1.5% after reporting quarterly results and announcing that the European CHMP's trend vote was negative for the Exondys 51 marketing authorization application.
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